How do I comply with the EU ABS Regulation?

If your research is within scope of by the EU ABS Regulation, go to the ABS Clearing-House to:
a) Determine whether the provider country is party to the Nagoya Protocol and whether there is any ABS legislation for genetic resources and/or associated traditional knowledge.
b) Obtain the contact information for the national focal point (NFP) and competent national authorities (CNA) in the country that holds the genetic resource and/or the associated traditional knowledge. The ABS Clearing-House should have information on how to apply for access – such as a flow chart or a where you can find more information on how to apply for access. If not, proceed to step 3.

Contact the national focal point in your provider country and seek advice as to:
a) How to apply for Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) and if there are any specific requirements or conditions attached to these permits.
b) Other specific and relevant national legislation that requires further permits.

If you launch a product in the market as a result of this research, you shall, before the product is introduced in the market or at the time of the product approval, submit a second declaration to the Swedish Environmental Protection Agency.

Guidance

Definitions

Definitions

For the purposes of this Regulation, the definitions of the Convention and the Nagoya Protocol as well as the following definitions apply:

access means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol

association of users means an organisation, established in accordance with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices referred to in Article 8 of this Regulation

collection means a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities

illegally accessed genetic resources means genetic resources and traditional knowledge associated with genetic resources which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent

internationally recognised certificate of compliance means a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-sharing Clearing House established under Article 14(1) of that Protocol

traditional knowledge associated with genetic resources means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources

utilisation of genetic resources means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention

prior informed consent (PIC) a permit or an equivalent document that has been issued at the time of access as proof of the compliance of applicable laws and regulations

mutually agreed terms (MAT): a contract between a provider of genetic resources or associated traditional knowledge and a user, within which the obligations are described that ensures that any potential benefit is shared fairly and equitably. Additional requirements may exist for subsequent users or at the time of product release to market

Background

Background

The aims of the UN Convention on Biological Diversity (CBD) are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. At the Conference of the Parties to the Convention on Biological Diversity (CBD) in 2010, the Nagoya Protocol governing access to genetic resources and fair and equitable sharing of their use was adopted.

In the EU, the Nagoya Protocol is implemented by Regulation (EU) No 511/2014 of the European Parliament and of the Council on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (also called the ABS Regulation).

This Regulation entered into force in October 2014. On 12 October 2015, one year after its entry into force, the Regulation’s provisions on the obligations of users of genetic resources began to apply within the EU.

Sweden is a signatory to the Nagoya Protocol, but has not yet ratified it. According to the Government Offices of Sweden, Sweden plans to ratify the Nagoya Protocol at the latest 90 days before the first meeting of the Parties to the Nagoya Protocol on Access and Benefit-Sharing in December 2016, in order to be a full member at this meeting. Before it can ratify the Protocol however, Sweden must have penalty provisions in place and a regulatory framework for access to traditional knowledge that is not acquired in the context of access to genetic resources. These provisions are likely to be decided on before the summer of 2016.

Tasked with the implementation of the ABS Regulation

In February 2015, the Swedish Environmental Protection Agency was tasked by the Government of Sweden with preparing for the implementation of the EU Regulation 511/2014 (ABS Regulation) on the implementation of the Nagoya Protocol. This task entailed:

Suggesting how best to organize and exercise national supervision of the ABS Regulation cost-effectively

Setting up a national focal point in the Internet-based Access and Benefit-Sharing Clearing House (ABS Clearing House) that has been established to provide information about access to genetic resources and benefit-sharing from the utilization of these resources

Initiating dialogue with representatives of users of genetic resources in both private and public sector activities in order to materially assist the implementation and facilitate compliance with the ABS Regulation.

How the Swedish EPA has been working on this task

In June 2015, the Swedish Environmental Protection Agency submitted a proposal to the Government concerning the supervision organization. This proposal suggested that both the Swedish Environmental Protection Agency and the Swedish Board of Agriculture should be competent authorities and share supervisory responsibility for the implementation. However, in January 2016 it became clear that the Swedish EPA needed to shoulder the entire responsibility for supervision, and therefore remains the only competent authority in Sweden. Since January, the Swedish EPA has been preparing in various ways to take on this responsibility, for example by developing a risk-based supervision plan and Guides for users.

The Swedish EPA has set up a national focal point by publishing Guides and other information on the Web.

The Swedish EPA now also has an organization for dealing with questions from stakeholders, and is ready to accept declarations from users.

Dialogue has been initiated through a hearing in the spring of 2015, and via e-mail communications with users of genetic resources.

On 22 April 2016, a seminar will be held to communicate the application of the ABS Regulation to different categories of users.

A report on this task was presented on 31 March 2016, at which time the Guides were also published.